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New Capstone, Inc MARCS-CMS 525164 —

New Capstone, Inc

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo


Division of Human and Animal Food
Operations West V
1431 Harbor Bay Parkway
Alameda, CA 94502 



September 07, 2017

Dr. Carolyn F. A. Dean, M.D.
New Capstone Inc.
52 Kainui Loop
Kihei, HI 96753

Dear Dr. Dean:

We received a letter from you, dated July 17, 2017. This correspondence was sent in response to a Warning Letter (WL #525164-17) dated June 28, 2017, sent to you from this office. The Warning Letter referenced findings from a review of your website by the U.S. Food and Drug Administration (FDA).

We have completed our evaluation of the corrective actions implemented in response to the letter. Based on our evaluation it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Matthew Walburger,
Acting Director Compliance Branch
Food and Drug Administration

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